NCT02501928

Open-label Long-term Extension Study of Fesoterodine in Japanese Subjects With Neurogenic Detrusor Overactivity.

LONG-TERM EXTENSION STUDY TO EVALUATE THE SAFETY OF FESOTERODINE IN JAPANESE PEDIATRIC SUBJECTS WITH SYMPTOMS OF DETRUSOR OVERACTIVITY ASSOCIATED WITH A NEUROLOGICAL CONDITION (NEUROGENIC DETRUSOR OVERACTIVITY) WHO HAVE COMPLETED 24 WEEKS TREATMENT IN STUDY A0221047

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 6 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to investigate the safety and tolerability of fesoterodine following once daily long-term treatment in Japanese pediatric neurogenic detrusor overactivity (NDO) subjects.

Detailed description

This is a Phase 3, multi-center, open-label long-term extension study in Japanese NDO subjects who participated and completed in the precedent Study A0221047 which is a 24 weeks, randomized, open label study, to investigate the safety and tolerability of fesoterodine. This study consists of a 28-week open-label treatment period followed by a 4-week follow-up. In addition, subjects in the oxybutynin arm of the precedent Study A0221047 will continue the fesoterodine treatment until Week 40 visit in this study, in order to obtain fesoterodine 1 year treatment data.

Conditions

• Urinary Bladder, Neurogenic

Interventions

Type	Name	Description
DRUG	Fesoterodine PR 4 mg	Fesoterodine 4 mg tablet once daily for 28 or 40 weeks
DRUG	Fesoterodine PR 8 mg	Fesoterodine PR 8 mg tablet once daily for 28 or 40 weeks
DRUG	Fesoterodine BIC 2 mg	Fesoterodine BIC 2 mg tablet once daily for 28 weeks
DRUG	Fesoterodine BIC 4 mg	Fesoterodine BIC 4 mg tablet once daily for 28 weeks

Timeline

• Start date: 2015-06-05
• Primary completion: 2020-04-01
• Completion: 2020-04-01
• First posted: 2015-07-17
• Last updated: 2020-11-30
• Results posted: 2020-10-26

Locations

7 sites across 1 country: Japan